Practice Areas

Admissions

New York Bar

Education

Rutgers School of Law - Camden, J.D. 1992

Rutgers, The State University of New Jersey, B.S. 1982

Joseph M. O’Malley, Jr. is a partner in the Intellectual Property practice at Paul Hastings. He has extensive patent litigation experience across a broad range of technologies, including chemicals and pharmaceuticals. Mr. O'Malley has served as lead trial counsel for many branded pharmaceutical clients including Pfizer, Merck, Abbott, Eisai, Sunovion (formerly Sepracor), and Takeda (formerly Nycomed), and has prevailed at trial and appeal in billion-dollar-a-year Hatch-Waxman Act pharmaceutical patent litigations.

Chambers USA (2015) says Mr. O’Malley “takes the helm on pharmaceutical cases on behalf of the leading names in the field.” The publication has referred to him as "the complete package" and cites his "winning combination" of a "tremendous work ethic, personable demeanor and litigation skills." Chambers USA (2016) recognizes him as a "good strategist," "charismatic" and a "subject matter expert." Sources also reserve praise for his "calm and unflappable demeanor" and business-focused approach. Chambers USA (2017) says the "excellent" Joseph O'Malley is highly rated for his work on complex IP issues in the life sciences space, where interviewees describe him as "a good strategic thinker." Sources say: "He is good at getting the big picture of litigations, including the business and political aspects."

IAM Patent 1000 ranks Mr. O’Malley in the Gold band noting him as a “true leader” in the space, and recognizing his work on the most high-profile, big-ticket work from the most demanding of clients. According to the publication, Mr. O’Malley "has driven the firm to huge success and is everything customers seek in a pharmaceutical patent litigator." The publication cites his “immense courtroom experience” that “shows each time he steps up to the plate” and has noted the “complex scenarios” he has handled “requiring creative strategies.” According to IAM Patent 1000 (2015): such is his standing among peers, he is hailed as “a great credit to the legal profession.” In IAM Patent 1000 (2016): “O’Malley is a challenging guy to litigate against – he is very comfortable in court and in command of all the issues at all times. He has amazing attention to detail and comes prepared with very effective game plans.” One highly ranked peer reported: “I have never seen anybody better than Joe in settling difficult conflicts on a win-win basis.”

LMG Life Sciences has recognized Mr. O’Malley among its “US Life Sciences Stars” and notes he is a “preeminent litigator in the industry.”

Dey, L.P., et al v. Sunovion Inc., S.D.N.Y (2009-2012) — In March of 2012, Paul Hastings secured a summary judgment ruling, on behalf of defendant Sunovion, that five of the seven patents asserted against Sunovion's Brovana® product were invalid under 35 U.S.C. 102(b) due to Sunovion's public use of the claimed subject matter during a clinical trial. The Court also held on summary judgment that plaintiffs were precluded from obtaining any damages for infringement of the two remaining patents which may have occurred during the four and a half years prior to the issuance of reexamination certificates for those patents. Following that summary judgment decision, and a later pre-trial claim construction decision in which the Court adopted every one of our client's proposed definitions, the case settled on confidential terms. Portions of the case are being appealed by plaintiffs Dey and Mylan.

Sunovion Inc. v. Teva Pharmaceuticals USA Inc. et. al., D.N.J. (2009 to present) — Mr. O’Malley was lead trial counsel on Sunovion’s behalf in one of the largest Hatch-Waxman Act cases ever filed, with 22 generic defendants. At issue were the patents protecting Sunovion’s Lunesta® (eszopiclone) sleeping agent. Lunesta® is Sunovion’s largest-selling drug product. In June 2010, Paul Hastings secured, on Sunovion’s behalf, a dismissal of inequitable conduct claims in a twenty two-defendant Hatch-Waxman litigation relating to Sunovion’s popular sleep aid Lunesta®. Judge Cavanaugh of the District of New Jersey issued one of the first post-Exergen Corp. v. Wal-Mart Store decisions dismissing a generic drug manufacturer’s inequitable-conduct defenses for failure to satisfy the “stringent pleading standard.” In April 2013, all defendants admitted that Sunovion’s patent is valid, obviating the need for a validity trial. In a September 2013 ruling in favor of Sunovion, the Federal Circuit reversed the district court’s entry of summary judgment in favor of Dr. Reddy’s Laboratories, which had been granted in January 2013. This reversal effectively prevented Dr. Reddy’s from entering the market with its generic Lunesta® product immediately upon approval, destroying the branded market for Sunovion’s largest drug product. The decision also makes new law, namely, that if a generic’s application to the FDA permits infringement, then it infringes as a matter of law, notwithstanding other evidence of noninfringement, in this case, a sworn Certification by Dr. Reddy’s, filed with the District Court, promising not to infringe.

Eisai Co., Ltd. and Eisai Inc. v. Teva Pharmaceuticals USA Inc., Dr. Reddy’s Laboratories and Mylan Laboratories, S.D.N.Y. — Mr. O’Malley was lead trial counsel on behalf of Eisai from 2004 through 2008 during the successful summary judgment proceedings and bench trial involving Eisai’s patent covering the company’s billion-dollar-a-year acid reflux and ulcer medication, Aciphex® (rabeprazole). As a result of those summary judgment proceedings and trial, Eisai’s patent was held valid, enforceable and infringed. The drug product represented 40% of the company's revenues at the time of trial and the patent life extended to 2013, resulting in several billions of dollars to the company being at stake. Mr. O’Malley also successfully argued the appeal to the Court of Appeals for the Federal Circuit resulting in affirmance of those trial court rulings. The Federal Circuit decision from that case has become an important weapon to branded pharmaceutical companies seeking to protect their basic composition-of- matter patents against unenforceability challenges, and against obviousness challenges following the Supreme Court’s decision in KSR.

Eisai Co., Ltd. v. Teva Pharmaceuticals USA, Inc., D.N.J. — Mr. O’Malley represents Eisai Co., Ltd. regarding the company’s two billion-dollar-a-year Alzheimer’s drug, Aricept® (donepizil hydrochloride). The generic drug maker charged that Eisai’s patent should be held unenforceable because Eisai had failed to disclose an allegedly related copending patent application of Eisai’s. In 2008, the U.S. District Court for the District of New Jersey granted Eisai’s motion for a preliminary injunction, finding that Eisai’s patent was valid and infringed and that Teva’s remaining defense of patent unenforceability lacked substantial merit. At the time, the preliminary injunction was only the fourth preliminary injunction ever granted by the District of New Jersey on behalf of branded pharmaceutical companies.

Biovail Labs. Int’l SRL v. Andrx Pharms., LLC and Andrx Corp., D. Del. — Mr. O’Malley was lead trial counsel on behalf of Biovail and its marketing partner Abbott Laboratories regarding their successful antihypertensive medication, Cardizem® LA. The case went to trial on November 13, 2007 in the U.S. District Court for the District of Delaware before Chief Judge Gregory M. Sleet. The parties settled the case after presentation of our clients’ case-in-chief, which included the testimony of one of our experts who presented the results of elaborate testing, which demonstrated that the generic product fell within the asserted patent claims after it is ingested (“in vivo”). In order to even permit his clients to get past summary judgment, Mr. O’Malley had to convince the Delaware Court to disregard a prior Markman decision and affirmed non-infringement ruling from the District of Florida and the Federal Circuit that rejected an in vivo claim construction of the same patent claims. The Florida case involved the same parties (though different counsel) and a product that was alleged by defendants to be the same as was at issue in the Delaware case.

Warner-Lambert Company v. Teva Pharmaceuticals Inc., D.N.J. — Mr. O’Malley was lead trial counsel on behalf of Pfizer (Warner-Lambert Company) during a successful bench trial involving Teva’s claims that Pfizer’s patent was invalid for lack of enablement. In its November 2007 decision, the District Court found that Pfizer’s formulation patent covering its cardiovascular drug Accupril® was not invalid for lack of enablement, despite the breadth of the claims. In obtaining this successful trial decision, the Paul Hastings team was able to distinguish a previous decision by the same District Court Judge, which held a pharmaceutical formulation patent of similar breadth to be invalid for lack of enablement. With that trial decision, all issues of infringement, enforceability and validity were decided in Pfizer’s favor in the case after eight years of litigation. The case then settled while the appeal of the enablement ruling was pending.

Pfizer, Inc. and Warner-Lambert Company v. Ranbaxy Pharmaceuticals and Teva Pharmaceuticals, D.N.J. — Mr. O’Malley was lead trial counsel on behalf of Pfizer bringing a successful preliminary injunction motion in 2005 against generics Teva and Ranbaxy, halting sales of their generic quinapril product. Mr. O’Malley also successfully argued the affirmance of that preliminary injunction to the Court of Appeals for the Federal Circuit. The case then settled prior to trial. This injunction has been widely hailed as the first preliminary injunction to be obtained against a generic that had already entered the market. In order to obtain the injunction, Mr. O'Malley had to convince the District Court and the Court of Appeals to accept a claim construction that he had expressly advocated against in a prior litigation in front of the same District Court Judge. Mr. O’Malley’s rare success in convincing the same Judge to accept the opposite claim construction to that he had previously, successfully advocated was featured in the June 2005 issue of The American Lawyer.

Warner-Lambert Company v. Teva Pharmaceuticals Inc., D.N.J. — Mr. O’Malley was lead trial counsel on behalf of Pfizer (Warner-Lambert) during a successful bench trial in which Senior Judge Debevoise of the District of New Jersey found that Pfizer's patent covering its highly successful Accupril® product was both valid and enforceable. The court had previously granted summary judgment of infringement in Pfizer's favor. Mr. O’Malley also argued the successful appeal to the Federal Circuit that resulted in the affirmance of these trial rulings on behalf of Pfizer.

Kos Pharmaceuticals v. Barr Laboratories Inc., S.D.N.Y. — Mr. O’Malley was lead trial counsel on behalf of Kos in this Hatch-Waxman Act litigation that covered the company's franchise Niaspan® product. In what was truly a bet-your-company case, the patents at issue in the litigation protected products accounting for 80% of the company's revenues. In the face of a threatened launch by the generic, a preliminary injunction motion was brought to halt the launch. The generic tabled its launch plans in view of the motion, and the case settled on terms favorable to our client Kos on the eve of the Court announcing its preliminary injunction decision.

Speaking Engagements and Publications

Widely quoted and published on a variety of topics relating to pharmaceutical patent litigation

Authored articles in both the mainstream media and in trade journals

Recently appeared on Bloomberg TV to discuss the growing trend of at-risk launches by generic pharmaceutical makers

Professional and Community Involvement

Prior to law school, Mr. O’Malley worked for seven years as a chemical engineer in DuPont’s engineering department, where he supervised the design and construction of new chemical and pharmaceutical processing facilities.

Currently on the Industrial Advisory Board of Rutgers College of Engineering

Upcoming Events

Rankings & Awards

Recognized by Chambers USA 2019Chambers USA 2019: America’s Leading Lawyers for Business listed the firm in 44 practice areas and named 107 firm lawyers to its rankings of leading lawyers and law firms in the United States.
April 26, 2019

Recognized by Managing IP as the Life Sciences IP Litigation Firm of the Year
Paul Hastings was was recognized by Managing IP at their Americas Awards, which honored individuals and companies behind the most innovative and challenging IP work of the past year, as well as those driving the international IP market.
The firm was recognized as Life Sciences IP Litigation Firm of the Year in the United States.
April 05, 2019

Recognized by Chambers Global 2019Chambers Global 2019: The World’s Leading Lawyers listed the firm in 37 research areas and named 59 firm lawyers to its rankings of leading lawyers and law firms adept in complex international work and with strong cross-border capabilities.
February 14, 2019

Recognized as the 2019 Post-Grant Firm of the Year by IAM Magazine
Paul Hastings was recognized as the Post-Grant Firm of the Year at Intellectual Asset Management's inaugural Global IP Awards. The award recognizes the achievements of the firm's Patent Trial and Appeal Board (PTAB) Team, which practices before the US Patent & Trial Office. Over the past year, the team's accomplishments include numerous post-grant proceeding victories for technology and life sciences clients - four of which were affirmed by the Court of Appeals for the Federal Circuit.
January 30, 2019

Recognized as LMG Life Sciences Stars for 2018
Paul Hastings was recognized in the 2018 edition of LMG Life Sciences, with Highly Recommended rankings for General Patent Litigation and Hatch-Waxman Branded Litigation. LMG Life Sciences selected seven individual lawyers as "Life Sciences Stars," including Eric Dittmann, Gary Giampetruzzi, Naveen Modi, Joseph O’Malley, Chad Peterman, Preston Ratliff, and Bruce Wexler. Earlier this year, LMG Life Sciences honored the firm with the LMG Life Sciences award for Hatch-Waxman Litigation Firm of the Year – Branded.
October 12, 2018

Recognized as the Hatch-Waxman Litigation Firm of the Year by LMG Life SciencesLMG Life Sciences announced that the firm’s Intellectual Property practice was honored at the LMG Life Sciences Awards as the Hatch-Waxman Litigation Firm of the Year (Branded). The publication cited the firm for wins on behalf of Sunovion Pharmaceuticals, which locked in compound patent protection for Latuda®, the company’s billion-dollar-plus-per-year schizophrenia and bipolar drug, after a judgment of infringement that was affirmed by the Federal Circuit; and for Orexigen Therapeutics after a trial victory where the judge found all three patents-in-suit to be valid and infringed. The firm was also noted for obtaining an unprecedented six walk-away consent judgments in a major pharmaceutical litigation.

The firm and its partners were also shortlisted for:
* Inter-Partes Review Firm of the Year
* Post Grant Proceedings Attorney of the Year: Naveen Modi
* General Patent Litigator of the Year – New York: Bruce Wexler
September 13, 2018

Recognized by Chambers USA 2018Chambers USA 2018: America’s Leading Lawyers for Business listed the firm in 45 research areas and named 112 firm lawyers to its rankings of leading lawyers and law firms in the United States.
May 15, 2018

Recognized as Law360 Practice Group of the Year in Life Sciences
Paul Hastings was named as a Practice Group of the Year in Life Sciences by Law360. The article noted Paul Hastings’ undefeated track record in life sciences cases at the Patent Trial and Appeal Board, including victories on behalf of Acorda Therapeutics, which won four inter partes reviews against Kyle Bass’ Coalition for Affordable Drugs. Law360 also highlighted the representation of Galena Biopharma in a civil-only settlement resolving investigations regarding Galena’s past promotional practices for Abstral, a rapid onset opioid product. The winners were chosen from nearly 750 submissions, and are recognized as "firms that racked up victories in litigation and closed the big deals to make their mark among clients and throughout the legal industry."
February 01, 2018

Joseph O’Malley was named an Intellectual Property
Trailblazer by the National Law Journal,
and profiled for his work on behalf of Helsinn Healthcare.

July 05, 2017

Paul Hastings IP Practice Honored in 2017 IAM Patent 1000
Intellectual Asset Management highlighted Paul Hastings' IP practice in IAM Patent 1000: The World's Leading Patent Professionals. The guide ranked the firm's practices Nationwide as well as in New York and Washington, DC. Paul Hastings partners were ranked in California: Yar Chaikovsky; New York: Joseph O'Malley; Gerald Flattmann; Preston Ratliff; Bruce Wexler; Samuel Waxman; Washington DC: Naveen Modi; Blair Jacobs; Joseph Palys; and Allan Soobert; and in Japan: Hiroyuki Hagiwara. Paul Hastings attorneys were also recognized in IAM's Nationwide tables: Yar Chaikovsky and Blair Jacobs were recommended for International Trade Commission litigation; Jacobs was recommended for his experience in Federal Circuit appellate litigation; and Naveen Modi and Joseph Palys were both recognized for their strength in post-grant proceedings. Preston Ratliff was also noted in the IAM Strategy 300, which recognizes individuals for their work in protecting intellectual property as a key business asset.
June 06, 2017

Recognized by Chambers USA 2017Chambers USA 2017: America’s Leading Lawyers for Business named 46 of the firm’s practice areas and 112 individuals to its ranking of leading lawyers and law firms in the United States.
June 05, 2017

Joseph O’Malley was named an MVP award winner by Law360
in the Intellectual Property category. Law360 reviewed more than
1,000 submissions, selecting attorneys with “successes in high-stakes
litigation, record-breaking deals and complex global matters” as this year’s
MVP award winners.

November 23, 2016

Benchmark Litigation 2017Benchmark Litigation recognized Yar Chaikovsky, Gerald Flattmann, Douglas Flaum, Holly House, Joseph O'Malley, Barry Sher, Peter Stone, William Sullivan, Bruce Wexler, William K. Whitner, and Thomas Zaccaro as Litigation Stars in its 2017 guide, which focuses exclusively on litigation in the United States. The guide is the result of six months of research, including extensive interviews with litigators and
clients as well as a close examination of recent casework handled by the firm. The firm was ranked in Tier 1 for U.S. Intellectual Property and as Highly Recommended in California.
October 21, 2016

Recognized at the 2016 LMG Life Sciences Awards
Paul Hastings was recognized with multiple LMG Life Sciences Awards. Bruce Wexler was named “General Patent Litigator of the Year – New York” and Naveen Modi was recognized as Post Grant Proceedings Attorney of the Year. The Life Sciences Patent Litigation practice also won awards for two Hatch-Waxman Impact Cases of the Year, including Helsinn Healthcare SA v. Teva Pharmaceuticals USA, a win resolving a long-running patent dispute over Aloxi®, a drug used to treat chemotherapy-induced nausea and vomiting.
The Paul Hastings team representing Helsinn was led by Joseph O’Malley. The firm was also honored for its work on behalf of Eli Lily in Sanofi-Aventis US v. Eli Lilly & Co., where Bruce Wexler led the team representing Eli Lily in litigation regarding the marketing of Basaglar®, its insulin glargine drug product. The case was settled in late 2015, with the press reporting Eli Lilly’s ability to launch the drug.
September 16, 2016

Shortlisted for four LMG Life Sciences Awards for 2016
The Firm was shortlisted in four categories for the LMG Life Sciences Awards. Joseph O’Malley was nominated in the Hatch-Waxman Litigator of the Year – Branded category, Bruce Wexler was nominated in the General Patent Litigator of the Year - New Yorkcategory, Naveen Modi was nominated in the Post Grant Proceedings Attorney of the Year category, and the Firm was nominated in the “Hatch-Waxman Litigation Firm of the Year – Branded” category.
July 27, 2016

Recognized by Chambers USA 2016Chambers USA 2016: America’s Leading Lawyers for Business named 47 of the firm’s practice areas and 112 individuals to its ranking of leading lawyers and law firms in the United States.
June 08, 2016

Benchmark Litigation recognized Yar Chaikovsky, Gerald Flattmann, Douglas Flaum, Holly House, Joseph O'Malley, Barry Sher, Peter Stone, William Sullivan, Bruce Wexler, and William K. Whitner as Litigation Stars in its 2016 guide, which focuses exclusively on litigation in the United States and is the result of six-months of research that includes extensive interviews with litigators, clients and a close examination of recent casework handled by the firm. The firm was ranked as Highly Recommended in California, and in Tier 2 for US Intellectual Property.

Additionally, the firm was shortlisted for the 2016 Benchmark Litigation US Awards in the State Firm Awards – California category, and Yar Chaikovsky was shortlisted in the Practice Area Attorneys of the Year – Intellectual Property category.

Paul Hastings Lawyers Honored by Law360 with MVP WinsMichael
Fitzgerald, Joseph
O’Malley and Thomas
Zaccaro were each named as MVP award winners by top-tier legal publication
Law360 based on their “success in high-stakes litigation, record-breaking deals
and complex global matters earned.” Michael Fitzgerald was recognized in the
Capital Markets category for his innovative FIBRA work and for advising on the
largest equity offerings in Mexico this year. Joseph O’Malley was recognized in
the Life Sciences category for his numerous litigation victories for
pharmaceutical companies including a patent infringement win for Sunovion that
made new law. And Thomas Zaccaro was recognized in the White Collar category
for innovative defense work in the technology and financial services sectors
and his successful defense of Manouch Moshayedi in one of the largest insider
trading cases ever brought by the U.S. Securities and Exchange Commission.
Law360 chose the 2014 MVPs out of over 800 submissions and it is one of the
legal publication’s most prestigious recognitions.
November 20, 2014

Recognized by LMG Life Sciences for Life Sciences IP Litigation
Paul Hastings' Life Sciences Intellectual Property practice received the highest possible ranking in Legal Media Group’sLife Sciences 2014 guide; as it was ranked “Highly Recommended” in the Hatch-Waxman Patent Litigation (Branded) and General Patent Litigation categories. Commentary from the guide singled out Joseph O’Malley and Bruce Wexler as “preeminent litigators in the industry” and pointed out Gerald Flattmann’s "ability to serve as lead counsel in important industry cases." The IP practice was also described as having “outstanding teams both for commercial patent litigation as well as in dealing with infringement suits on the branded Hatch-Waxman front.”
October 09, 2014

Jeff Randall, Joseph O'Malley, Gerald Flattmann, Bruce Wexler, Melanie Rupert and Christopher Kennerly were named 2014 IP Stars by Managing Intellectual Property magazine. Nationwide, the firm's Intellectual Property practice was
ranked in the Bio/Life Sciences, Copyright and Patent Contentious categories. In New York, the firm's IP practice was ranked
Highly Recommended in the Patent Contentious category and in California, the IP
practice was ranked Recommended in the Copyright and Patent Contentious
categories.

April 29, 2014

Legal Media Group's 2013 LMG Life Science Awards
The firm was nominated as a 2013 LMG Life Science nominee in the “Litigation Team of the Year” and “(General) Patent Litigation: Firm of the Year” categories.
August 12, 2013